Autosomal Dominant Polycystic Kidney Clinical Trial
— PoCKETOfficial title:
Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease
Investigator initiated controlled multi-centre trial in a Prospective, Randomised, Open,
Blinded Endpoint (PROBE) design.
Patients will be randomised in a 1:1 ratio either to treatment with tolvaptan for six weeks
followed by six weeks observation without trial medication or no tolvaptan treatment, but
following the same visit and investigation plan as the subjects taking tolvaptan.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | April 2020 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Adult patients between 18 and 65 years - Diagnosis of typical ADPKD - tKV above or equal to 750 ml by MRI scanning - Estimated GFR (e-GFR) by CKD-EPI formula of above or equal to 45 mL/min/1.73 m2 Exclusion Criteria: - Kidney transplant recipient - Known liver disease except for liver cysts relating to ADPKD - ASAT and ALAT above upper normal level - Current treatment with thiazide and thiazide-line diuretics, mineral corticoid receptor antagonists, amiloride or loop diuretics - Evidence of urinary tract obstruction - Current treatment with CYP3A4 inhibitors - Active malignant disease - Current or previous treatment with tolvaptan |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet - Site 42 | Copenhagen | |
Denmark | Herlev Hospital | Herlev | |
Denmark | Nordsjaellands Hospital - Site 41 | Hillerød | |
Denmark | Odense University Hospital - Site 45 | Odense | Odense C |
Denmark | Sjællands University Hospital Roskilde | Roskilde | |
Denmark | Aarhus University Hospital - Site 43 | Skejby | Aarhus N |
Lead Sponsor | Collaborator |
---|---|
Lisbet Brandi |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in total Kidney Volume (tKV) measured by MRI scanning | The change in the total Kidney Volume after six and 12 weeks participation in the trial | Between baseline and six weeks and between six and 12 weeks | |
Secondary | Changes in GFR | The changes in GFR measured by Cr-EDTA clearance | Between baseline and six weeks and between baseline and 12 weeks | |
Secondary | Changes in relevant genetic and non-genetic biomarkers associated with CKD and ESRD | Prediction of change in progression of the disease over time in the genes PKD1, PKD2, PKHD1 and HNF1B. The following biomarkers will be determined: NGAL, UMOD, MCP-1, KIM-1, cystatin-C and copeptin | Between baseline and six weeks and between baseline and 12 weeks | |
Secondary | Changes in Quality of Life | Questionnaire SF36 Health Survey - with 36 questions to subject's health and wellbeing | Between baseline and six weeks and between baseline and 12 weeks | |
Secondary | Subject estimation of own health | Estimated by a Visual Analogue Scale from 0 (worth wellbeing) to 100 (best wellbeing | Between baseline and six weeks and between baseline and 12 weeks | |
Secondary | Changes in ASAT and ALAT | Changes estimated from laboratory results | Between baseline and six weeks and between baseline and 12 weeks | |
Secondary | Incidence of Adverse Events | Evaluation of Adverse Events including severity, causality, outcome and seriousness assessments | Between baseline and six weeks and between baseline and 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04310319 -
Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt
|
N/A | |
Terminated |
NCT04064346 -
Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease
|
Phase 3 | |
Completed |
NCT03203642 -
Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
|
Phase 2 | |
Recruiting |
NCT05500157 -
Assessment of Treatment With Laparoscopic Fenestration or Aspiration Sclerotherapy for Large Symptomatic Hepatic Cysts
|
N/A | |
Recruiting |
NCT04111692 -
A Prospective Observational Study of Foam Sclerotherapy .
|
||
Recruiting |
NCT04907799 -
Daily Caloric Restriction in ADPKD
|
N/A | |
Completed |
NCT05401409 -
Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease
|
N/A | |
Terminated |
NCT03918447 -
A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
|
Phase 3 | |
Terminated |
NCT03749447 -
An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
|
Phase 3 | |
Recruiting |
NCT05228574 -
Treatment of Vascular Stiffness in ADPKD
|
Phase 4 | |
Completed |
NCT04908462 -
To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT03858439 -
Dietary Intervention in ADPKD on Tolvaptan
|
N/A | |
Recruiting |
NCT06391450 -
Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease (EMPA-PKD)
|
Phase 4 | |
Recruiting |
NCT05478083 -
A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
|
Phase 2 | |
Completed |
NCT03102632 -
A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
|
N/A | |
Recruiting |
NCT05996731 -
Developing a Pipeline to Employ RNA-Seq as a Complementary Diagnostic Tool in Rare Diseases
|
N/A | |
Recruiting |
NCT06193616 -
Outcome of ADPKD With Octreotide LAR
|
||
Completed |
NCT05646420 -
Thyroid Hormones in ADPKD
|
N/A | |
Completed |
NCT03366337 -
A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
|
Phase 2 | |
Active, not recruiting |
NCT03273413 -
Statin Therapy in Patients With Early Stage ADPKD
|
Phase 4 |